FDA.reportPublic FDA data

NDC 58198-0013 - T8 Keto Flush

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58198-0013
Package NDCs from labels
58198-0013-1, 58198-0013-2
Manufacturer
Elanco US Inc.
Effective date
2025-10-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Elanco ™ T8 Keto™ FLUSHElanco US Inc.2025-10-28PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58198-0013-1T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-1T8 Keto Flush118 mL in 1 BOTTLE, PLASTICSOLUTION1183
58198-0013-2T8 Keto Flush1 in 1 BOTTLE, PLASTICSOLUTION13
58198-0013-2T8 Keto Flush355 mL in 1 BOTTLE, PLASTICSOLUTION3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58198-0013T8 KETO FLUSH (KETOCONAZOLE) SOLUTION [ELANCO US INC.]24 package rows20230420_2fff06d2-c883-4d8a-af7a-958b5fe9746f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
unii: R9400W927I
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEZydus Lifesciences Limitedc004ee91-558a-450b-9e4e-d11ab9d280542025-03-12Exact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLECosette Pharmaceuticals, Inc.2d7c8dd1-59b5-2645-e063-6394a90a5bda2025-02-06Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%NuCare Pharmaceuticals,Inc.05f9938a-1577-adec-e063-6294a90af3492025-01-31Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEDirect_Rxf5dc1e67-639f-5476-e053-2995a90a42102025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KETOCONAZOLEKETOCONAZOLEDirect Rxbc189ce2-3f10-260d-e053-2a95a90ae8082025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLENuCare Pharmaceuticals,Inc.570acb82-0c6f-0b98-e054-00144ff8d46c2024-12-26Warnings, Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEBryant Ranch Prepackac98307e-315a-4fbd-81cb-cd936f2bfbae2024-12-24Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetodanKETOCONAZOLEMedimetriks Pharmaceuticals, Inc.62f19bd8-926e-4e6b-9097-d81b894b95cc2024-12-05Warnings, Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEBryant Ranch Prepack77989858-9f7a-45d6-97fb-deba1cba8fe82024-10-08Warnings, Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEBryant Ranch Prepack513370d5-2e9f-4677-a0f2-63ff761429092024-10-08Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEBryant Ranch Prepackd0fcab34-5451-456a-a75a-b1365d5dbc2c2024-06-20Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd99da5233-2760-46f6-8fb3-d9df5da70bfb2024-05-31Adverse reactionsExact identifier
unii: R9400W927I
KETOCONAZOLEKETOCONAZOLEBryant Ranch Prepack3ea8a22b-cd61-4623-a11f-43e3396b50fa2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEBryant Ranch Prepackb200ef76-5ea1-4253-bea5-1e8db02945102024-03-15Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEViona Pharmaceuticals Inca4bb3f4c-ad93-4d85-b8d0-54eaa62228fd2024-03-11Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLE CREAM, 2%Proficient Rx LP36e0bdcb-845c-452f-ad5a-a116ad657a3a2024-03-01Warnings, Adverse reactionsExact identifier
unii: R9400W927I
ketoconazoleKETOCONAZOLEPadagis Israel Pharmaceuticals Ltd9b65f632-a98d-400e-9ec3-84dea581d6a32024-02-29Warnings, Adverse reactionsExact identifier
unii: R9400W927I
KetoconazoleKETOCONAZOLEBryant Ranch Prepack02a348b0-1325-4298-8813-83970da32c7a2024-01-11Warnings, Adverse reactionsExact identifier
unii: R9400W927I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.